Cleared Traditional

K915081 - MITEK SNAP PAK(TM), MODIFICATION (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915081 · Mitek Surgical Products, Inc. · General & Plastic Surgery device
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Jan 1992
Decision
80d
Days
Class 2
Risk

K915081 is an FDA 510(k) clearance for the MITEK SNAP PAK(TM), MODIFICATION. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K915081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1991
Decision Date January 31, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 114d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.